Ohm Recalls Loratadine Tablets Due to Out-of-Specification Assay
Ohm Laboratories is recalling Loratadine Orally Disintegrating Tablets because an out-of-specification assay result indicated the drug was superpotent.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Ohm Laboratories, Inc. is recalling Loratadine Orally Disintegrating Tablets USP, 10 mg, due to an out-of-specification (OOS) result for assay. The source text identifies the issue as a "Superpotent Drug," meaning the tablets contain more active ingredient than the standard specification allows.
The affected product is distributed by CVS Pharmacy, Inc. and Walgreen Co. The recall involves 2,592 blister packs with Lot # 2625094 and an expiration date of 06/2016. The distribution pattern is listed as nationwide.
Consumers should stop using the affected medication and return it to the pharmacy where it was purchased for a refund or replacement. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack, a) Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428113677 (CVS brand, b) Distributed by: Walgreen Co. 20
- Manufacturer
- Ohm Laboratories, Inc.
- Category
- Drug — Antihistamine
- Hazard
- Affected units
- 2,592
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 2625094
- Exp 06/2016
Distribution
Distributed nationwide across the United States.
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